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AbbVie preps JAK atopic dermatitis candidate for phase 3

Analysts say the data seems to match that for Sanofi and Regeneron's recently approved Dupixent.

AbbVie has chalked up positive phase 2b data for its JAK1 inhibitor upadacitinib, setting up a late-stage program and a potential challenge to Sanofi and Regeneron's Dupixent in the evolving atopic dermatitis market.

Upadacitinib (ABT-494), a JAK1 inhibitor, met its objective of improving the symptoms of atopic dermatitis (also known as eczema) in the study, relieving itchiness and improving the chances of clearing skin lesions in patients with moderate-to-severe disease.

Analysts at Jefferies think the midstage data suggest that the orally active drug seems comparable to IL-4 and IL-13 blocker Dupixent (dupilumab)—which is given by injection—although they stress that no head-to-head comparison data is available. They have previously said the drug could become a $3.5 billion product if it claims approval in other inflammatory conditions including rheumatoid arthritis and inflammatory bowel disease.

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In the trial, half of patients receiving the highest dose of upadacitinib achieved a 90% or more improvement in skin lesions by week 16, compared to 2% of the placebo group, while itchiness improved by 69% versus 10% for the dummy treatment.

The data "show that upadacitinib has the potential to be an important treatment option for patients with atopic dermatitis," said Michael Severino, M.D., AbbVie's chief scientific officer. "We look forward to advancing upadacitinib to phase 3 studies in 2018."

For years, atopic dermatitis patients could only rely on elderly treatment options such as emollients and topical steroids to manage their symptoms. That changed late last year when Pfizer added to options available with its topical drug Eucrisa (crisaborole), a gel formulation of the PDE-4 inhibitor drug intended for patients with mild-to-moderate symptoms that has been tipped to make peak sales of $2 billion.

Since then, Dupixent made its debut for patients with moderate-to-severe symptoms, and initial uptake has been encouraging for its developers, with Sanofi recording sales of around $25 million in its first full quarter on the market. The French drugmaker has estimated that around 1.6 million people out of the 18 million to 25 million with the disease in the U.S. have symptoms that are uncontrolled with current therapies.

Galderma's IL-31-targeting nemolizumab, Leo Pharma's IL-13 inhibitor tralokinumab and rival IL-13 lebrikizumab—recently licensed to Dermira by Roche—are also being developed as injectable therapies for moderate-to-severe atopic dermatitis but are still in midstage development.

As an oral therapy, upadacitinib could become an attractive alternative to injectables for the chronic condition, something that has not escaped other companies operating in the space. In December, Novartis bought U.K. biotech Ziarco in order to get its hands on its oral H4 receptor antagonist ZPL-389, in phase 2. Meanwhile, rival JAK inhibitors including Eli Lilly and Incyte's baricitinib, are also in trials in atopic dermatitis.

GlobalData has predicted that new therapies will help boost the atopic dermatitis market from $3.6 billion in 2014 to $7.3 billion in 2024.